Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 7, 2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantit… - a moderate-severity action.
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantit… was recalled by Siemens Healthcare Diagnostics, Inc. in September 7, 2022. Reason: Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of de…. Check the official notice for the remedy. Verify recall #Z-1648-2022 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of de….
- Moderate
- severity level
- 129 units
- affected scope
- Class II
- classification
- September 7, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1648-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1648-2022) was formally reported on September 7, 2022, with the manufacturer initiating the action on July 18, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 129 units US; 159 units OUS.
The documented reason for this recall is: Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
129 units US; 159 units OUS
Related Recalls
6
3 from same agency
Product description
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Reason for recall
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1648-2022 |
| Date reported | September 7, 2022 |
| Date initiated | July 18, 2022 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 129 units US; 159 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland. |
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-1648-2022) 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? ▼
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 129 units US; 159 units OUS.
Why was this product recalled? ▼
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1648-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1648-2022) 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 September 7, 2022. 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.