Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 D
FDA device recall Z-0499-2007 · 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
- 800 packages of 50 strips each.
- 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
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