PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
FDA Recall Z-1419-05 · Posted 2005-08-30
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Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGGW
Date Initiated2005-04-13
Date Terminated2006-10-03
Product Quantity740 kits
Reason for Recall
Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
Firm Action
On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
Root Cause
Other
Distribution Pattern
The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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