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FDA Medical Device Recalls (openFDA)

Abbott Laboratories, Inc.: Precision PCx Test Strips Part Number: 98757-12

Recall number
Z-0403-03
Recalling firm
Abbott Laboratories, Inc.
Product
Precision PCx Test Strips Part Number: 98757-12
Status
Terminated
Initiated
2002-11-08
Posted
2002-12-31
Terminated
2017-02-13
Reason
Use of glucose blood strips may provide false high results
Root cause
Other
Action
Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Quantity
210 packages
Distribution
NC, WI
Lot, serial or model codes
Lot Number: 146135
510(k) numbers
["K983504"]
PMA numbers
not on file
Product code
CGA
Firm FEI
3002803444
Firm city
Bedford
Firm state
MA
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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

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