Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported January 1, 2020
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
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 w…
Tosoh Smd Inc recalled AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/co… — a low-severity action.
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/co… was recalled by Tosoh Smd Inc in January 1, 2020. Reason: The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequat…. Check the official notice for the remedy. Verify recall #Z-0745-2020 with the FDA Devices before acting.
The recall
Tosoh Smd Inc issued this low-severity FDA Devices recall — The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequat….
- Low
- severity level
- 1K units
- affected scope
- Class III
- classification
- January 1, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0745-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0745-2020) was formally reported on January 1, 2020, with the manufacturer initiating the action on November 15, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Tosoh Smd Inc is listed as the recalling firm, operating out of Grove City, OH. Federal records list the affected scope as 1012 units.
The documented reason for this recall is: 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 sc… Distribution data in the federal record shows the product reached: Nationwide Foreign: Columbia, Dominic Republic, Ecuador. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
1012 units
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0745-2020 |
| Date reported | January 1, 2020 |
| Date initiated | November 15, 2019 |
| Recalling firm | Tosoh Smd Inc |
| Firm location | Grove City, OH |
| Affected scope | 1012 units |
| Distribution | Nationwide Foreign: Columbia, Dominic Republic, Ecuador |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0745-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706. Recalled by Tosoh Smd Inc. Units affected: 1012 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2020. Severity: Low. Recall number: Z-0745-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Columbia, Dominic Republic, Ecuador.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0745-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 1, 2020.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.