FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: Lactate Disposable Membrane Caps Product Number: 0018108400
- Recall number
- Z-0027-04
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- Lactate Disposable Membrane Caps Product Number: 0018108400
- Status
- Terminated
- Initiated
- 2003-08-28
- Posted
- 2003-10-15
- Terminated
- 2012-05-23
- Reason
- Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
- 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
- 287 boxes
- Distribution
- IL, NY International: Italy, Mexico
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNW
- Firm FEI
- 1217183
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28