Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somers
FDA device recall Z-1110-2010 · posted 2010-03-12 · Terminated
Recall details
- Recalling firm
- NERL Diagnostics Corporation
- Reason for recall
- Unreactive Staph latex reagent
- Action taken
- NERL Diagnostics notified distributors on January 15, 2010, by letter to advise of the recall and request they examine inventory, discontinue use of affected lot numbers and discard any remaining inventory. In addition, if product was further distributed, notify the customers of the product recall. If you have any questions, please telephone 1-401-824-2046.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWX
- Quantity affected
- 125 kits
- Distribution
- NJ
- Date initiated
- 2010-01-15
- Date posted
- 2010-03-12
- Date terminated
- 2011-10-05
- Location
- East Providence, RI
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