Lactate Disposable Membrane Caps Product Number: 0018108400

FDA device recall Z-0027-04 · posted 2003-10-15 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

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.

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.

Root cause

Other

Status

Terminated

Product code

LNW

Quantity affected

287 boxes

Distribution

IL, NY International: Italy, Mexico

Date initiated

2003-08-28

Date posted

2003-10-15

Date terminated

2012-05-23

Location

Lexington, MA