Tosoh Smd Inc: Medical Device Recall in 2020 - (Recall #: Z-0745-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

Product Classification:

Class III

Date Initiated: November 15, 2019

Date Posted: January 1, 2020

Recall Number: Z-0745-2020

Event ID: 84299

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.

Status: Terminated

Product Quantity: 1012 units

Code Information:

Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30

Distribution Pattern:

Nationwide Foreign: Columbia, Dominic Republic, Ecuador

Voluntary or Mandated:

Voluntary: Firm initiated