Z-1020-2011

i-STAT Level 2 Control Value Assignment Sheets Human Consumption

Name: Z-1020-2011 i-STAT Level 2 Control Value Assignment Sheets Human Consumption
Creator: Abbott Point of Care Inc.
Published: 2010-08-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-08-03 / Terminated / root cause: software

FDA source

Abbott Point of Care Inc. began a recall of i-STAT Level 2 Control Value Assignment Sheets Human Consumption on 2010-08-03. The reason FDA records is "Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1020-2011
Status: Terminated
Initiated: 2010-08-03
Posted: 2011-02-02
Terminated: 2011-09-28
Recalling firm: Abbott Medical
Product: i-STAT Level 2 Control Value Assignment Sheets Human Consumption
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.
Root cause tag: software
FDA root cause: Other
Action: Abbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on 8/3/2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. The Business Reply card is to be completed and returned to Abbott. Questions or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1.
Quantity in commerce: 8293 Value sheets worldwide
Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.
Product codes and lots: Abbott List Number: 06F13-01; Lot number B09342 - CLEW A20 artwork 726778-01A.pdf; Lot number B09154 - CLEW A20 artwork 726774-01A.pdf; Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010. Abbott List Number: 025715, CLEW A20 Compact Disc containing value assignment sheets.

Product code JJY

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)