Recall Z-1505-06 ยท LHJ Staphylococcus Aureus Protein A Insoluble
Becton Dickinson & Co.
BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.
| Date | Sep 16, 2006 (initiated Aug 17, 2006) |
| Status | Terminated |
| Reason | False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component. |
| Root cause | Other |
| Action | The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06. |
| Quantity | 1,572 kits |
| Distribution | Worldwide-product was sold to distributors and end users |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.