Device Recall STA

K9483518 D029396 Lot #106775

Hematology and Pathology Devices

2

No

Worldwide Distribution and USA (Nationwide) and including Canada

STA - System Control N + P || Product Usage: || The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase¿¿ time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit.

510 k K083746  Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)

Immunology and Microbiology Devices

1

No

Nationwide Distribution-including the states of NJ, NY, and PA.

Status Flu A + B Test || Manufactured by || Princeton Bio Meditech Corporation || Monmouth Junction, NJ 08852 USA. || The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

K082248 D089976 Ref 58104 units

Hematology and Pathology Devices

2

No

Worldwide Distribution - USA (nationwide) and Canada

STA Satellite Automated Multi-Parameter Analyzer || This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.

Anesthesiology Devices

2

No

Nationwide Distribution including IL, OH, NY and TN.

Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. || The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Lot JUWJF283

General Hospital and Personal Use Devices

1

No

National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).

StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.