Z-1048-04

ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and...

Name: Z-1048-04 ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-06-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-06-11 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics... on 2004-06-11. The reason FDA records is "False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1048-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-07-20
Terminated: 2004-10-05
Recalling firm: Abbott Medical
Product: ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
Product code: GTZ Antisera, All Groups, Streptococcus Spp.
Reason for recall: False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
FDA root cause: Other
Action: A Device Recall Letter was sent to customers that received the affected product lots on 6/11/04 via Federal Express Priority. The accounts were informed of the false positive readings, and were requested to destroy any affected inventory of the recalled lots.
Quantity in commerce: 75,368 kits
Distribution: The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany
Product codes and lots: List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200. List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.

Product code GTZ

K971522Class IAbbott Testpack Plus Strep a with on Board Controls (Obc) IIAbbott Laboratories / cleared 1998-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)