Z-1111-2010

Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured...

Name: Z-1111-2010 Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured...
Creator: NERL Diagnostics Corporation
Published: 2010-01-15
License: https://open.fda.gov/license/

NERL Diagnostics Corporation / initiated 2010-01-15 / Terminated / root cause: manufacturing process

FDA source

NERL Diagnostics Corporation began a recall of 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... on 2010-01-15. The reason FDA records is "Unreactive Staph latex reagent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1111-2010
Status: Terminated
Initiated: 2010-01-15
Posted: 2010-03-12
Terminated: 2011-10-05
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.
Product code: JWX Kit, Screening, Staphylococcus Aureus
Reason for recall: Unreactive Staph latex reagent
Root cause tag: manufacturing process
FDA 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 in commerce: 146 kits
Distribution: NJ
Product codes and lots: Lot Numbers: 0919119 and 1110049 Exp. Date 06/03/2012

Product code JWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)