Z-0671-2019Class II

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of...

Name: Z-0671-2019 AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of...
Creator: Tosoh Bioscience Inc
Published: 2018-11-30
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-11-30 / Terminated / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA... on 2018-11-30. FDA classified it as Class II and gives the reason as "Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0671-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Posted: 2018-12-22
Terminated: 2021-01-14
Recalling firm: Tosoh Bioscience Inc
Product: AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
Product code: CDD Radioassay, Vitamin B12
Reason for recall: Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Root cause tag: design
FDA root cause: Device Design
Action: On November 30, 2018, Tosoh Bioscience issued Urgent Medical Device Recall notices to customers. Customers are advised to take the following actions: " Do not use the assays identified in notice for those patients who have recently had a fluorescein angiography procedure. For these patients, use an alternative testing method that does not use a fluorescein-based technology. " Inform medical professionals that the Tosoh AIA assays in the notice utilize a fluorescein-based technology and should not be used to test patient samples for patients who have recently undergone fluorescein angiography. " Continue to use the Tosoh AIA assays listed in notice only for patients who have not undergone a fluorescein angiography procedure exam, or on patient samples which have been taken prior to receiving the fluorescein angiography procedure. " Complete & return the Urgent Medical Device Recall Acknowledgement Form within 15-days of receiving the notification. " Maintain a copy of the notification with your laboratory records and forward this information to others who may have received this product. Should you have any questions, please contact Bernadette OConnell at 1(800) 248-6764 or by email at [email protected]. She will be able to answer any questions Monday-Friday from 9 AM to 5 PM (PST).
Quantity in commerce: 29645 units
Distribution: US Nationwide
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0671-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0671-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0672-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0673-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0674-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0675-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0676-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code CDD

K964348Class IIAia-Pack B12 AssayTosoh Medics, Inc. / cleared 1997-01-13

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)