ClearanceBrief
Recall Z-0403-03 ยท CGA Glucose Oxidase, Glucose

Abbott Laboratories, Inc.

Precision PCx Test Strips Part Number: 98757-12

DateDec 31, 2002 (initiated Nov 8, 2002)
StatusTerminated
ReasonUse of glucose blood strips may provide false high results
Root causeOther
ActionAbbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Quantity210 packages
DistributionNC, WI
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K983504PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
Medisense, Inc., Jul 9, 1999