FDA Medical Device Recalls (openFDA)
NERL Diagnostics Corporation: Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
- Recall number
- Z-1111-2010
- Recalling firm
- NERL Diagnostics Corporation
- Product
- Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
- Status
- Terminated
- Initiated
- 2010-01-15
- Posted
- 2010-03-12
- Terminated
- 2011-10-05
- Reason
- Unreactive Staph latex reagent
- Root cause
- Process control
- Action
- 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.
- Quantity
- 146 kits
- Distribution
- NJ
- Lot, serial or model codes
- Lot Numbers: 0919119 and 1110049 Exp. Date 06/03/2012
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JWX
- Firm FEI
- 1215667
- Firm city
- East Providence
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28