Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minu
FDA device recall Z-0498-2007 · posted 2007-02-17 · Terminated
Recall details
- Recalling firm
- EMD Chemicals Inc
- Reason for recall
- Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
- Action taken
- A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
- Root cause
- Other
- Status
- Terminated
- Product code
- J
- Quantity affected
- 8 rolls
- Distribution
- Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
- Date initiated
- 2006-08-17
- Date posted
- 2007-02-17
- Date terminated
- 2008-06-06
- Location
- Gibbstown, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.