Atlas FDA

Precision PCx Test Strips Part Number: 98757-12

FDA device recall Z-0403-03 · posted 2002-12-31 · Terminated

Recall details

Recalling firm
Abbott Laboratories, Inc.
Reason for recall
Use of glucose blood strips may provide false high results
Action taken
Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Root cause
Other
Status
Terminated
Product code
CGA
Quantity affected
210 packages
Distribution
NC, WI
Date initiated
2002-11-08
Date posted
2002-12-31
Date terminated
2017-02-13
Location
Bedford, MA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST (K983504)Medisense, Inc.1999-07-09