Instrumentation Laboratory Co. Lactate Disposable Membrane Caps Product Number: 0018108400 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lactate Disposable Membrane Caps Product Number: 0018108400
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
US Distribution Lot Numbers: N307, Exp. 1/30/04 N30601
Products Sold
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
Instrumentation Laboratory Co. is recalling Lactate Disposable Membrane Caps Product Number: 0018108400 due to Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, NY
Page updated: Jan 10, 2026