Z-1812-2018Class II

Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended...

Name: Z-1812-2018 Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended...
Creator: Tosoh Bioscience Inc
Published: 2018-03-05
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-03-05 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the... on 2018-03-05. FDA classified it as Class II and gives the reason as "The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results". 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-1812-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-05
Posted: 2018-05-14
Terminated: 2020-06-16
Recalling firm: Tosoh Bioscience Inc
Product: Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Product code: N/A
Reason for recall: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.
Quantity in commerce: 2258
Distribution: USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1812-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1810-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1811-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1812-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14

Product code N/A

K100304Class IISt Aia Pack Hba1cTosoh Bioscience, Inc. / cleared 2010-08-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)