Lot No. 1545171

Immunology and Microbiology Devices

1

No

US Distribution to the states of : MI, ND, SC, TN, and TX.

Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.

lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15

Immunology and Microbiology Devices

2

No

Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

lot 740340920, expiration 14APR16; lot 740350820, expiration 22JUL16;

Immunology and Microbiology Devices

2

No

Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;

Immunology and Microbiology Devices

2

No

Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

Lot no. 15037, Expires: 00-00-2000

Immunology and Microbiology Devices

1

No

Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.

Hardy Diagnostics cat no. G327 HardyCHROM SS Agar || (HardyCHROM Salmonella Shigella) || Cat no: G327 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2 to 8 degrees C. on receipt in dark || A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

Lot No. 27333

Immunology and Microbiology Devices

2

No

Internationally: Denmark only.

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

lot 286303720, expiration 08-APR-15

Immunology and Microbiology Devices

2

No

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220, 30-OCT-15; lot 287324240, 30-OCT-15; lot 287326220, 19-NOV-15; lot 287327620, 03-DEC-15; lot 287329620, 23-DEC-15; lot 287330520, 01-JAN-16; lot 287331920, 15-JAN-16; lot 287332520, 21-JAN-16; lot 287332522, 21-JAN-16; lot 287334810, 13-FEB-16; lot 287335420, 19-FEB-16; lot 287336220, 27-FEB-16; lot 287337620, 12-MAR-16; lot 287338020, 16-MAR-16; lot 287340140, 06-APR-16; lot 287341820, 23-APR-16; lot 287341822, 23-APR-16; lot 287344620, 21-MAY-16; lot 287344622, 21-MAY-16; lot 287346710, 11-JUN-16; lot 287346720, 11-JUN-16; lot 287350120, 15-JUL-16; and lot 287350122, 15-JUL-16.

Immunology and Microbiology Devices

2

No

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.

Immunology and Microbiology Devices

2

No

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.

MicroScan -Neg Breakpoint Combo Panel Type 34; || Catalog number B1017-404; Panel || MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to || No.1 the species level of colonies, grown 34 on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria

Lot Number: 646595 and 646596 Expiration date: 19May2015

Immunology and Microbiology Devices

1

No

Nationwide Distribution.

Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). || Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

Serial numbers: 0169039201140624, 0169040501140626, 0169050101141007, 0169068601141216, 0169078101150213, 2163X1013, 2164X1013, 2165X1013, 2166X1013, 2167X1013, 2168X1013, 2169X1013, 2170X1013, 2171X1013, 2172X1013, 2173X1013, 2174X1013, 2175X1013, 2176X1013, 2177X1013, 2178X1013, 2179X1013, 2180X1013, 2181X1013, 2182X1013, 2183X1013, 2184X1013, 2185X1013, 2186X1013, 2187X1013, 2188X1013, 2189X1013, 2190X1013, 2191X1013, 2192X1113, 2193X1113, 2194X1113, 2195X1113, 2196X1113, 2199X1113, 2201X1113, 2202X1113, 2203X1113, 2204X1113, 2205X1113, 2206X1113, 2207X1113, 2208X1113, 2209X1113, 2210X1113, 2211X1113, 2212X1113, 2213X1113, 2214X1113, 2216X1113, 2217X1113, 2218X1213, 2219X1213, 2220X1213, 2221X1213, 2222X1213, 2223X1213, 2224X1213, 2225X1213, 2226X1213, 2227X1213, 2228X1213, 2229X1213, 2230X1213, 2231X1213, 2232X1213, 2233X1213, 2234X1213, 2235X1213, 2237X1213, 2238X1213, 2239X1213, 2240X1213, 2241X1213, 2242X1213, 2243X1213, 2245X1213, 2249X0114, 2250X0114, 2251X0114, 2252X0114, 2253X0114, 2254X0114, 2255X0114, 2256X0114, 2257X0114, 2261X0114, 2262X0114, 2263X0114, 2264X0114, 2268X0114, 2269X0114, 2276X0214, 2277X0214, 2278X0214, 2279X0214, 2280X0214, 2281X0214, 2282X0214, 2286X0214, 2287X0214, 2288X0214, 2289X0214, 2290X0214, 2306X0714, 2307X0714, 2309X0714, 2311X0714, 2312X0714, 2314X0714, 2315X0714, 2316X0714, 2317X0714, 2318X0714, 2320X0714, 2321X0814, 2322X0814, 2323X0814, 2330X0814, 2332X0814, 2333X0814, 2334X0814, 2336X0814, 2337X0814, 2338X0814, 2339X0814, 2340X0814, 2342X0814, 2345X0914, 2346X0914, 2347X0914, 2348X0914, 2349X0914, 2352X0914, 2353X0914, 2359X0914, 2365X0914, and 2366X0914;

Immunology and Microbiology Devices

1

No

Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.

VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

Immunology and Microbiology Devices

2

No

Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.

IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;

Immunology and Microbiology Devices

1

No

Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.

VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

1002774320, 1002377890, 1002590470, 1002775330, 1002379610

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

Cat No.: G333 Lot No.: H15055

Immunology and Microbiology Devices

2

No

Distributed to one U.S. customer in SC.

HardyCHROM VRE Agar-RSR || Cat no: GA333 Lot no: H15055 || Expires: 2015-07-04 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage 2 to 8 degrees C on receipt || Chromogenic medium for stool pathogen screening.

Lot Number 0073853 (US distribution only)

Immunology and Microbiology Devices

2

No

Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.

Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 || The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Lot number: 15096 and 15107

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || MacConkey Agar with CiPRP, 1ug/ml || Container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.

Lot number: 15055, 15083, and 15091

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || BHI with CIPRO, 1ug/ml || container type: 16x100mm tube || packaged: 20 tubes/box || Product Usage: || Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.

lot 1470133, exp. date 31 Mar 2016

Immunology and Microbiology Devices

1

No

Nationwide Distribution, including Puerto Rico and the country of Canada.

PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. || Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.

lot 1463129, exp. date 31 May 2016

Immunology and Microbiology Devices

1

No

Nationwide Distribution, including Puerto Rico and the country of Canada.

PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. || Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

Lot number: 15092, 15101, 15113 Cat no. G259

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || MDR Acinetobacter || container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || BEA Agar with Vancomycin || container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

Lot number: 15105 Cat no. G107

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || BEA Agar with VGA || container type: 15x100mm monoplate || packaged: 10 places/sleeve || Product Usage: || BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).

Lot number: 15070 Cat no. R98  Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72

Immunology and Microbiology Devices

2

No

U.S. Nationwide Distribution and the country of: Canada

Hardy Diagnostics || BEA Broth with Vancomycin || container type: 13x100mm tube || packaged: 20 tubes/box || fill: 2ml || Product Usage: || BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting