BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in
FDA device recall Z-1505-06 · posted 2006-09-16 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- 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.
- Action taken
- The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LHJ
- Quantity affected
- 1,572 kits
- Distribution
- Worldwide-product was sold to distributors and end users
- Date initiated
- 2006-08-17
- Date posted
- 2006-09-16
- Date terminated
- 2007-03-09
- Location
- Sparks, MD
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