Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 18, 2023
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in bot…
Ventana Medical Systems, Inc. recalled VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VEN… - a moderate-severity action.
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VEN… was recalled by Ventana Medical Systems, Inc. in January 18, 2023. Reason: Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of …. Check the official notice for the remedy. Verify recall #Z-0907-2023 with the FDA Devices before acting.
The recall
Ventana Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of ….
- Moderate
- severity level
- Class II
- classification
- January 18, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0907-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0907-2023) was formally reported on January 18, 2023, with the manufacturer initiating the action on November 18, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ventana Medical Systems, Inc. is listed as the recalling firm, operating out of Oro Valley, AZ. Federal records list the affected scope as 8,927 kits.
The documented reason for this recall is: Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent pos… Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA…. 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
8,927 kits
Related Recalls
6
3 from same agency
Product description
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Reason for recall
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0907-2023 |
| Date reported | January 18, 2023 |
| Date initiated | November 18, 2022 |
| Recalling firm | Ventana Medical Systems, Inc. |
| Firm location | Oro Valley, AZ |
| Affected scope | 8,927 kits |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. Th… |
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-0907-2023) 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? ▼
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001. Recalled by Ventana Medical Systems, Inc.. Units affected: 8,927 kits.
Why was this product recalled? ▼
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0907-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom, Albania, Armenia, Bangladesh, Belarus, Costa Rica, Cote d'Ivoire, Cuba, Dominican Republic, Egypt, El Salvador, Ghana, Guatemala, Iran, Israel, Jordan, Kenya, Kosovo, Kuwait, Lebanon, Mauritius, Morocco, Myanmar, Nigeria, North Macedonia, Oman, Panama, Philippines, Russian Fed., Saudi Arabia, Serbia, South Africa, Tanzania, Turkey, Turkmenistan and United Arab Emirates. Update (04-Jan-2023): Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Honduras, Indonesia, India, Japan, Korea, Mexico, Malaysia, New Zealand, Peru, Pakistan, Paraguay, Singapore, Thailand, Taiwan, Uruguay and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0907-2023) 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 January 18, 2023. 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.