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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Laboratories (IL)

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 Class 2 Device Recall Instrumentation Laboratories (IL)see related information
Date Initiated by FirmAugust 28, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on May 23, 2012
Recall NumberZ-0027-04
Recall Event ID 27163
Product Classification Paper, Obstetric Ph - Product Code LNW
ProductLactate Disposable Membrane Caps Product Number: 0018108400
Code Information 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 
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
113 Hartwell Avenue
Lexington MA 02173
For Additional Information ContactCarol Marble
781-861-4467
Manufacturer 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 Determined
Cause 2		Other
ActionInstrumentation 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 Commerce287 boxes
DistributionIL, NY International: Italy, Mexico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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