Z-1997-2013Class II

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical...

Name: Z-1997-2013 Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical...
Creator: Beckman Coulter Inc.
Published: 2013-07-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-07-17 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human... on 2013-07-17. FDA classified it as Class II and gives the reason as "Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1997-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Posted: 2013-08-22
Terminated: 2014-10-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Product code: KHE Reagent, Occult Blood
Reason for recall: Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Product Correction letter dated July 9, 2013, to all affected customers. The letter was accompanied with a cover letter and response form, dated July 9, 2013. Customers were informed of the product under recall with product description, actions to take, contact information, the issue, impact, and resolution. Beckman Coulter conducted a risk assessment for this issue. Per the risk documentation, there is only a remote probability that use of the product will cause any adverse health consequences,and the product is not likely to lead to serious adverse health consequences. If you have any questions please call (714) 961-3777.
Quantity in commerce: 68,116 units
Distribution: Worldwide Distribution - USA and the country of Canada.
Product codes and lots: Part Number 395067. All In-date lots (42 lots total). Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1997-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22

Product code KHE

K080812Class IIHemoccult IctBeckman Coulter, Inc. / cleared 2008-06-25

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)