Software version 3.29

Clinical Chemistry and Clinical Toxicology Devices

2

No

United States only, nationwide.

Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

623207 626000 628294 628296

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.

Access Ostase Calibrators, Catalog No. 37305, B83876 || Product Usage: || The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.

628297 623207 626001

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.

Access Ostase QC, Catalog No. 37309, B83877 || Product Usage: || The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- United States and Canada.

Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. || Intended to be used with the Access Immunoassay System to remove waste from the system.

Part Number A48196/6845C; Instrument part numbers 81600 and  81600N

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution and Canada

Access Power Supply Assembly Sled || Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.

All Lots.

Clinical Chemistry and Clinical Toxicology Devices

1

No

USA and Canada.

Access Progesterone Assay, Part number 33550.

All lot numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Zambia, Zimbabwe.

Access Total BhCG (BhCG) Assay Part Number 33500 || The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide), Canada, and internationally.

Access Total T3 Reagent, PN: 33830 || The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

Part Number 33410, Lot Numbers: 714362 (Exp dt. 3/31/09), 716129 (Exp dt. 6/30/09), 718258 (Exp dt. 7/31/09), 519096 (Exp dt. 10/31/07), 521487 (Exp dt. 2/28/08), 616274 (Exp dt. 7/31/08), 617890 (Exp dt. 7/31/08), 617891 (Exp dt. 7/31/08) and 620204 (Exp dt. 12/31/08)

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide: including USA and Canada.

Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318.

AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ || The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ACCU-CHEK Compact Plus Test Strips || For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip || 51 count retail strip; 102 count retail strip; 51 count MedBen strip || 51 count Mail Order strip; Sample Kit 16 per case. || The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Clinical Chemistry and Clinical Toxicology Devices

1

No

There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

ACCU-CHEK Connect Diabetes Management App; Instruction Manual || Designed to transfer data for diabetes management.

All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

ACCU-CHEK Inform meter; catalog No. 3035123.

All units.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

ACCU-CHEK Instant Care Kit; Catalog number 91490.

All units.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

All units.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Guam.

Roche brand AccuData GTS/GTS Plus System || Replacement Base/Module; Catalog number 3426050, material number 03426050001.

Lot Numbers: 090013, 090121, and 090372

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation

Active INTACT PTH, Part Number: DSL-8000 || The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use.

Lot Numbers: 992751

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation

Active I-PTH ELISA, Part Number: DSL-10-8000 || The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.

Lot Number: 890291

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide distribution: USA including states of: FL, GA and NC.

Active Prolactin ELISA, 96 Wells, DSL-10-4500 || The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

Part Number 411100, Lot Number: 09177A

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.

Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)

All ADVIA 1200 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1200 Part # 094-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.

ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

Product Codes: 1) 10386841, 2) 10469445

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.

ADVIA 1200 System Software: 1) V2.00, 2) V2.01. || Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.

All ADVIA 1650 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1650 Part # 073-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.

ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

Product Codes: 1) 10318424, 2) 10285281

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.

ADVIA 1650 System Software: 1) V4.01, 2) V3.52. || Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.