Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 22, 2018
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Distribution of unapproved product labeling
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tosoh Bioscience Inc recalled Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD conta… - a low-severity action.
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD conta… was recalled by Tosoh Bioscience Inc in August 22, 2018. Reason: Distribution of unapproved product labeling. Check the official notice for the remedy. Verify recall #Z-2827-2018 with the FDA Devices before acting.
The recall
Tosoh Bioscience Inc issued this low-severity FDA Devices recall-Distribution of unapproved product labeling.
- Low
- severity level
- Class III
- classification
- August 22, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2827-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2827-2018) was formally reported on August 22, 2018, with the manufacturer initiating the action on June 5, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Tosoh Bioscience Inc is listed as the recalling firm, operating out of Grove City, OH. Federal records list the affected scope as 9 CDS.
The documented reason for this recall is: Distribution of unapproved product labeling Distribution data in the federal record shows the product reached: US Distribution to states of: FL, MA, MT, OK, OR and WI.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
9 CDS
Related Recalls
6
3 from same agency
Product description
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Reason for recall
Distribution of unapproved product labeling
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2827-2018 |
| Date reported | August 22, 2018 |
| Date initiated | June 5, 2018 |
| Recalling firm | Tosoh Bioscience Inc |
| Firm location | Grove City, OH |
| Affected scope | 9 CDS |
| Distribution | US Distribution to states of: FL, MA, MT, OK, OR and WI. |
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-2827-2018) 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? ▼
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.. Recalled by Tosoh Bioscience Inc. Units affected: 9 CDS.
Why was this product recalled? ▼
Distribution of unapproved product labeling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Low. Recall number: Z-2827-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: FL, MA, MT, OK, OR and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2827-2018) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 22, 2018. 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 July 2026.