Lactate Disposable Membrane Caps Product Number: 0018108400
This recall has been terminated (originally issued October 15, 2003).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- August 28, 2003
- Posted
- October 15, 2003
- Terminated
- May 23, 2012
- Recall Number
- Z-0027-04
- Quantity
- 287 boxes
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
Distribution
IL, NY International: Italy, Mexico
Lot / Code Info
US Distribution Lot Numbers: N307, Exp. 1/30/04 N30601, Exp 12/30/03 International Distribution: N30301 Exp 9/30/03 N30501 EXp 11/30/03 N306 Exp 12/30/03 N30604 Exp 12/30/03 N308 Exp 2/28/04
Root Cause
Other
Action Taken
Instrumentation Laboratories notified two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s). IL service also dispatched to customer sites on September 4, 2003. International Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, 2003, to IL personnel worldwide.