Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0499-2007

Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck...

EMD Millipore Corporation / initiated 2006-08-17 / Terminated

EMD Chemicals Inc began a recall of Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany on . The reason FDA records is "Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0499-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
EMD Millipore Corporation
Product
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
Product code
J
Reason for recall
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present
FDA root cause
Other
Action
A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Quantity in commerce
800 packages of 50 strips each.
Distribution
Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Product codes and lots
Item # 1.15112.0001 Lot # OC553145