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Terminated

Lactate Disposable Membrane Caps Product Number: 0018108400

FDA Recall Z-0027-04 · Posted 2003-10-15

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeLNW
Date Initiated2003-08-28
Date Terminated2012-05-23
Product Quantity287 boxes

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

IL, NY International: Italy, Mexico

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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