Z-0745-2020Class III

AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number...

Name: Z-0745-2020 AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number...
Creator: Tosoh Smd Inc
Published: 2019-11-15
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2019-11-15 / Terminated / root cause: design

FDA source

Tosoh Smd Inc began a recall of AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 on 2019-11-15. FDA classified it as Class III and gives the reason as "The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the...". 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-0745-2020
Classification: Class III
Status: Terminated
Initiated: 2019-11-15
Posted: 2019-12-26
Terminated: 2020-07-01
Recalling firm: Tosoh Bioscience Inc
Product: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Product code: CDD Radioassay, Vitamin B12
Reason for recall: The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle. In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.
Root cause tag: design
FDA root cause: Device Design
Action: Tosoh Bioscience issued Urgent Medical Device Correction on 11/15/19, letter states reason for recall, health risk and action to take: Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX, email, or postal mail as indicated on the form. In the event you receive Error Code 2220, discard the affected vial(s). You may pre-screen pretreatment 1 vials on AIA-2000 analyzers prior to reconstituting the vial to help identify vials that may return Error Code 2220. This is an optional pre-screen step and is not required for use of vials from the impacted lots. This is a voluntary customer notification that should be provided to all staff members operating the Tosoh AIA-2000 Analyzer.. Please maintain awareness of this notification by filing it with your laboratory records and forward this information to others who may have received this product. Should you have any questions regarding this medical device notification, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at [email protected]. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 1012 units
Distribution: Nationwide Foreign: Columbia, Dominic Republic, Ecuador
Product codes and lots: Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0745-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0745-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-26

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)