# FDA recall Z-0745-2020

> **Tosoh Smd Inc** · Class III · device recall initiated 2019-11-15.

## Product

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

## 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.

## Distribution

Nationwide  Foreign: Columbia, Dominic Republic, Ecuador

## Key facts

- **Recall number:** Z-0745-2020
- **Recalling firm:** Tosoh Smd Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2020-01-01
- **Termination date:** 2020-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0745-2020

## Citation

> AI Analytics. FDA recall Z-0745-2020. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0745-2020. Source: US FDA. Licensed CC0.

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