Z-1503-2012

Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin...

Name: Z-1503-2012 Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin...
Creator: MichClone Associates, Inc.
Published: 2012-02-23
License: https://open.fda.gov/license/

MichClone Associates, Inc. / initiated 2012-02-23 / Terminated / root cause: manufacturing process

FDA source

MichClone Associates, Inc. began a recall of Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100... on 2012-02-23. The reason FDA records is "Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1503-2012
Status: Terminated
Initiated: 2012-02-23
Posted: 2012-05-09
Terminated: 2012-12-13
Recalling firm: MichClone Associates, Inc.
Product: Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
Product code: GHM Test, Sickle Cell
Reason for recall: Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the perf
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: [email protected]. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
Quantity in commerce: 400 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot# 1187, expiration date: 7/13 Catalog No.13-2101, Powder Lot # 1171 (part of kit)

Product code GHM

K860812Class IISickle Cell Reagent SetMichclone Associates, Inc. / cleared 1986-04-11

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)