Recall Z-1020-2011 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Abbott Point of Care Inc.
i-STAT Level 2 Control Value Assignment Sheets Human Consumption
| Date | Feb 2, 2011 (initiated Aug 3, 2010) |
| Status | Terminated |
| 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 re |
| 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, Bra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.