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C.D.RICH
Chengdu Rich Science Industry Co., Ltd. · Model Is-urine collector 100ml · UDI-DI 16935238804445
10
510(k) clearances
1,021
Adverse events
29
Recalls
65
Facilities
Description
It is used for collection, transportation, storage and treatment of body fluid specimen, include stool,urine,sputum,Pathological effusion etc.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2021-02-16 | Vectornate USA Inc | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.