i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i

FDA device recall Z-0929-2011 · posted 2011-01-20 · Terminated

Recall details

Recalling firm

Abbott Point of Care Inc.

Reason for recall

Two cartridge lots were identified that may generate falsely elevated PCO2 results.

Action taken

Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them. For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.

Root cause

Other

Status

Terminated

Product code

CHL

Quantity affected

55350 total cartridges

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and th

Date initiated

2010-08-03

Date posted

2011-01-20

Date terminated

2011-12-05

Location

Princeton, NJ

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