Z-0027-04

Lactate Disposable Membrane Caps Product Number: 0018108400

Name: Z-0027-04 Lactate Disposable Membrane Caps Product Number: 0018108400
Creator: Instrumentation Laboratory Co.
Published: 2003-08-28
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2003-08-28 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of Lactate Disposable Membrane Caps Product Number: 0018108400 on 2003-08-28. The reason FDA records is "Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0027-04
Status: Terminated
Initiated: 2003-08-28
Posted: 2003-10-15
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: Lactate Disposable Membrane Caps Product Number: 0018108400
Product code: LNW Paper, Obstetric Ph
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.
FDA root cause: Other
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.
Quantity in commerce: 287 boxes
Distribution: IL, NY International: Italy, Mexico
Product codes and lots: 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

Product code LNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)