FDA Medical Device Recalls (openFDA)
Abbott Point of Care Inc.: i-STAT Level 2 Control Value Assignment Sheets Human Consumption
- Recall number
- Z-1020-2011
- Recalling firm
- Abbott Point of Care Inc.
- Product
- i-STAT Level 2 Control Value Assignment Sheets Human Consumption
- Status
- Terminated
- Initiated
- 2010-08-03
- Posted
- 2011-02-02
- Terminated
- 2011-09-28
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- 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
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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