Z-0290-2018Class II

Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01

Name: Z-0290-2018 Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
Creator: Remel Inc
Published: 2017-12-08
License: https://open.fda.gov/license/

Remel Inc / initiated 2017-12-08 / Terminated

FDA source

Remel Inc began a recall of Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify... on 2017-12-08. FDA classified it as Class II and gives the reason as "The serum may fail to agglutinate within the specified minimum reaction time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0290-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Posted: 2017-12-26
Terminated: 2020-07-22
Recalling firm: Remel Inc
Product: Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Product code: GNB Antisera, All Types, Shigella Spp.
Reason for recall: The serum may fail to agglutinate within the specified minimum reaction time.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 12/8/2017 via regular mail. The letter identified the affected product, problem and actions to be taken. The risk to health is also explained. The customer is requested to notify any personnel who need to be aware of the potential for incorrect performance specification for the product. The customer is to inspect their stock and destroy any remaining inventory of the lots listed. They are to contact Customer Service or their local distributor for replacement. A response form was to be returned acknowledging receipt of the notice and disposal of the affected product. If the product was further distributed, the customer was requested to contact their downstream customers, advise them of the recall, and provide them a copy of the recall letter.
Quantity in commerce: 237 units (single bottles)
Distribution: US Nationwide Distribution
Product codes and lots: UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bottle lot #1847290; Kit lot #2161363, Bottle lot #1847290; Kit lot #1984639, Bottle lot #1847290; Kit lot #1738564, Bottle lot#1738565; Kit lot #1971308, Bottle lot #1738565; Kit lot #1957305, Bottle lot #1738565; Kit lot #1947930, Bottle lot #1738565; and Kit lot #1847285, Bottle lot #1738565.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0290-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26

Product code GNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)